Actively Recruiting
The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.
Led by Shanghai Changzheng Hospital · Updated on 2025-09-03
64
Participants Needed
2
Research Sites
263 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Thyroid-associated ophthalmopathy (TAO) is an organ-specific autoimmune disease closely related to thyroid disease, which leads the incidence of orbital disease in adults and is the most common cause of diffuse toxic goiter (Graves disease, GD). The clinical manifestations of TAO are complex and varied. In severe cases, it may seriously impair visual function, affect daily life, and even cause corneal ulceration, perforation, and blindness. Therefore, a reasonable and effective treatment plan should be chosen according to the degree of TAO. Tetuzumab (IBI311) is a fully human monoclonal insulin-like growth factor-1 receptor inhibitory antibody. It has binding activity against IGF-1R positive cells, can block the binding of IGF-1 and IGF-2 to IGF-1R, and has a dose-dependent effect. It can inhibit the proliferation of HT29 cells caused by the activation of the IGF-1R signaling pathway. Meanwhile, it can dose-dependently inhibit the proliferation of orbital fibroblasts and the secretion of hyaluronic acid (HA) in patients with TAO. However, there are still significant gaps in the existing research evidence: the lack of head-to-head studies of temumab and glucocorticoids. The aim of this clinical study is to: 1. To evaluate the efficacy of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment. 2. To observe the safety of IBI311 treatment in patients with active moderate to severe TAO in the initial treatment. 3. Head-to-head comparison of sequential hormone therapy and IBI311 therapy in patients with active moderate to severe TAO in the initial treatment.
CONDITIONS
Official Title
The Safety and Efficacy of Sequential Hormone Therapy and IBI311 Therapy in Patients With Active Moderate to Severe TAO in the Initial Treatment.
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed with thyroid-associated ophthalmopathy by Bartley criteria
- Moderate to severe disease as defined by EUGOGO
- Clinical activity score (CAS) of 4 or higher on the 7-item scale in the study eye
- No prior glucocorticoid treatment for thyroid-associated ophthalmopathy
You will not qualify if you...
- Need for urgent intervention due to sight-threatening complications or rapid vision worsening
- Presence of other lesions in the orbit
- Previous orbital radiotherapy or surgery for thyroid eye disease, including decompression, strabismus surgery, or eyelid correction
- History of tinnitus or hearing impairment or abnormal audiometry results during screening
- Elevated liver enzymes (AST or ALT) more than 3 times normal, active hepatitis B infection, or current hepatitis B treatment
- Poor kidney function with glomerular filtration rate below 30 ml/min/1.73m2
- Poorly controlled diabetes defined as glycated hemoglobin 7.0% or higher or recent medication changes
- Poorly controlled hypertension with high blood pressure or recent changes in antihypertensive drugs
- Abnormal ECG showing very low or high heart rate, active heart disease, or QTcF prolongation above specified limits
- Positive HIV, hepatitis C antibodies, or active syphilis infection
- Prior systemic steroid use for thyroid-associated ophthalmopathy
- Any major illness or unstable condition increasing participant risk or interfering with safety assessment
- Any condition impairing ability to comply with study procedures or interpret data
- Pregnant or breastfeeding women
AI-Screening
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Trial Site Locations
Total: 2 locations
1
Shanghai Changzheng Hospital
Changhua, Shanghai Municipality, China, 200003
Actively Recruiting
2
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, China, 200003
Not Yet Recruiting
Research Team
T
Tuo Li, Vice Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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